Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes (Cinétique DAPA)

March 4, 2026 updated by: Centre Hospitalier Universitaire Dijon

Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes

This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca.

The information will:

  • reveal what is not working properly
  • make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning

This biomedical research will take place at the University Hospitals of DIJON and NANTES.

  • 28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.
  • The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.
  • Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.
  • Participation in the study will last 6 months and include 4 protocol visits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Dijon, France, 21079
        • Chu Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • persons who have provided written consent
  • type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)
  • Stable treatment for 3 months
  • HbA1c between 7.5% and 10%
  • Age between 30 and 65 years
  • BMI between 25 and 35 kg/m²
  • Triglycerides < 300 mg/dl
  • Half of the patients being treated with statins
  • eGFR > 75 ml/min/1.73 m² at inclusion

Exclusion Criteria:

  • persons without national health insurance cover
  • patients treated with Insulin or a GLP-1 agonist
  • Patients under guardianship
  • patients treated with lipid-lowering drugs (except statins for 50% of patients)
  • kidney failure
  • liver failure or abnormal liver function ASAT or ALAT >3 x upper limit of normal
  • total bilirubin >2mg/dl
  • intestinal disease
  • serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies)
  • Pregnancy, breastfeeding
  • hypersensitivity to the active substance or to excipients
  • patients with volume depletion, for example due to an acute disease (gastro-intestinal disease)
  • patients treated with loop diuretics or thiazides

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients not treated with statins
Drug: Dapagliflozin
Dapagliflozin 10 mg daily per os
Drug: Placebos
Placebo of Dapagliflozin per day per os
Experimental: Patients treated with statins
Drug: Dapagliflozin
Dapagliflozin 10 mg daily per os
Drug: Placebos
Placebo of Dapagliflozin per day per os

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline the rate of production of VLDL Apo B
Time Frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of IDL Apo B
Time Frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of LDL Apo B
Time Frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of HDL Apo A1
Time Frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B
Time Frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B
Time Frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of IDL Apo B
Time Frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of LDL Apo B
Time Frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1
Time Frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
15 days before treatment initiation, Day 0, Day 90 and Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 6, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VERGES AZ 2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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